Boehringer Ingelheim has received approval from the U.S. Food and Drug Administration (FDA) for its new oral therapy, JASCAYD (nerandomilast), for the treatment of idiopathic pulmonary fibrosis (IPF) in adults. This marks the first and only approval of a preferential phosphodiesterase 4B (PDE4B) inhibitor for this indication, offering a novel mechanism of action with both antifibrotic and immunomodulatory effects.
IPF is a rare, chronic, and progressive lung disease characterized by irreversible scarring of lung tissue. The approval of JASCAYD provides a new option for patients by slowing the decline in lung function—a key marker of disease progression.
“This milestone represents a new era in the treatment of IPF,” said Dr. Toby Maher, Professor of Clinical Medicine at the Keck School of Medicine, USC. “Nerandomilast is a welcome new treatment option with a well-tolerated safety profile for physicians to consider for appropriate patients.”
The FDA’s decision is based on positive results from two clinical trials: FIBRONEER™-IPF and Trial 2, which measured changes in Forced Vital Capacity (FVC), a standard metric of lung function. In FIBRONEER™-IPF, patients treated with 18 mg and 9 mg of nerandomilast experienced significantly smaller declines in FVC at 52 weeks (-106 mL and -122 mL, respectively), compared to the placebo group (-170 mL). The treatment effect was evident as early as week two and continued through the one-year study period.
Adverse effects were generally manageable, with the most common being diarrhea, upper respiratory infections, and decreased appetite. Discontinuation due to side effects occurred in 15% of patients on the 18 mg dose and 12% on the 9 mg dose, compared to 11% in the placebo group. Notably, there were no warnings or precautions listed in the FDA-approved label.
“The FDA approval of nerandomilast is a pivotal moment for people living with IPF,” said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. “This is the first time in over a decade that the treatment landscape for IPF is evolving.”
Scott Staszak, President and CEO of the Pulmonary Fibrosis Foundation, echoed the significance of the approval, noting the long-standing need for new therapies: “Nerandomilast provides an important addition to the care landscape.”
With JASCAYD’s approval, Boehringer Ingelheim strengthens its leadership in pulmonary medicine, offering hope to the IPF community with an innovative, mechanism-based treatment option.